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Development and Evaluation of the Effectiveness of the SMART-HAND Protocol for Hand Rehabilitation in Patients With Rheumatoid Arthritis

13 sierpnia 2026 zaktualizowane przez: Busra Turk, Istanbul University - Cerrahpasa
Rheumatoid arthritis (RA) frequently affects the hand and wrist, resulting in pain, reduced joint stability, impaired proprioception, muscle weakness, and limitations in daily activities. Although conventional rehabilitation primarily focuses on range of motion and strengthening exercises, sensorimotor impairments such as proprioceptive deficits are often underaddressed. The SMART-HAND (Sensory, Massage, Approximation, ROM, Training = Strengthening + Perturbation) protocol was developed as a structured, mechanism-based rehabilitation program to improve proprioception, joint stability, motor control, and hand function. This randomized controlled trial aims to evaluate the effectiveness of the SMART-HAND protocol in individuals with RA by comparing its effects on hand function, proprioception, pain, dexterity, muscle strength, and functional performance with conventional rehabilitation and a control group.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

132

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Participants will be 18 years of age or older.
  • Participants will have a diagnosis of rheumatoid arthritis for at least five years.
  • Participants will be referred by a rheumatologist.
  • Participants will have been on a stable medication regimen for the past three months.
  • Participants will have no history of diabetes mellitus.
  • Participants will have no other conditions affecting sensory function.
  • Participants will provide informed consent to participate in the study.

Exclusion Criteria:

  • Individuals who have undergone hand surgery within the past six months.
  • Individuals with a history of upper extremity fracture within the past six months.
  • Individuals with other musculoskeletal pain conditions involving the muscles and/or joints.
  • Individuals diagnosed with a neurological disease that may affect sensory or motor function.
  • Individuals who are unable to fully cooperate with the assessment procedures.
  • Individuals who have received corticosteroid treatment within the past month.
  • Individuals diagnosed with another rheumatic disease.
  • Pregnant women.
  • Individuals who are illiterate.

Withdrawal/Discontinuation Criteria

  • Participants who miss more than 10% of the intervention sessions will be excluded from the study.
  • Participants who change their medication dosage or medication class during the study period will be excluded from the study.
  • Participants will have the right to withdraw from the study at any time and for any reason.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: SMART-HAND Protocol
Participants assigned to the SMART-HAND Protocol Group will receive a supervised 12-week hand rehabilitation program consisting of two 50-minute sessions per week (24 sessions in total). The SMART-HAND protocol includes massage, sensory training, joint approximation, range of motion exercises, stretching, strengthening exercises, and perturbation-based stabilization training. Exercise progression will be individualized according to participants' tolerance using the Borg Rating of Perceived Exertion scale and progressive resistance. The intervention is designed to improve proprioception, sensorimotor integration, dynamic joint stability, muscle strength, and hand function.
Behawioralne: SMART-HAND Protocol
The SMART-HAND Protocol is a supervised, mechanism-based hand rehabilitation program administered twice weekly for 12 weeks (24 sessions, 50 minutes per session). The protocol consists of sensory training, massage, joint approximation, range of motion exercises, stretching, strengthening exercises, and perturbation-based stabilization training. Exercise progression is individualized according to participants' tolerance using the Borg Rating of Perceived Exertion scale and progressive resistance. The intervention is designed to improve proprioception, sensorimotor control, joint stability, muscle strength, and hand function.
Aktywny komparator: Conventional Hand Rehabilitation Group
Participants assigned to the Conventional Hand Rehabilitation Group will receive a supervised 12-week conventional hand exercise program consisting of two 50-minute sessions per week (24 sessions in total). The program includes range of motion, stretching, and strengthening exercises. Exercise intensity and progression will be individualized according to participants' tolerance using the Borg Rating of Perceived Exertion scale and progressive resistance. The intervention primarily aims to improve joint mobility, muscle strength, and hand function.
Behawioralne: Conventional Hand Rehabilitation
Participants will receive a supervised conventional hand rehabilitation program twice weekly for 12 weeks (24 sessions, 50 minutes per session). The program includes range of motion, stretching, and strengthening exercises. Exercise intensity and progression will be individualized according to participants' tolerance using the Borg Rating of Perceived Exertion scale and progressive resistance.
Aktywny komparator: Usual Care + Education Group
Participants assigned to the Usual Care + Education Group will continue to receive their routine medical care and will attend a single educational session lasting approximately 20-30 minutes. The education will include joint protection principles, ergonomic recommendations, and strategies for performing activities of daily living. No supervised exercise program will be provided during the 12-week study period.
Behawioralne: SMART-HAND Protocol
The SMART-HAND Protocol is a supervised, mechanism-based hand rehabilitation program administered twice weekly for 12 weeks (24 sessions, 50 minutes per session). The protocol consists of sensory training, massage, joint approximation, range of motion exercises, stretching, strengthening exercises, and perturbation-based stabilization training. Exercise progression is individualized according to participants' tolerance using the Borg Rating of Perceived Exertion scale and progressive resistance. The intervention is designed to improve proprioception, sensorimotor control, joint stability, muscle strength, and hand function.
Behawioralne: Joint Protection and Ergonomic Education
Participants will receive a single face-to-face education session lasting approximately 20-30 minutes. The education will include information on joint protection techniques, ergonomic principles, energy conservation, and recommendations for performing activities of daily living. Participants will continue their routine medical care throughout the study but will not receive a supervised exercise program.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Michigan Hand Outcomes Questionnaire (MHQ)
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12 (Primary endpoint: change from baseline to Week 12)
The Michigan Hand Outcomes Questionnaire (MHQ) will be used to assess hand function, activities of daily living, pain, work performance, aesthetics, and patient satisfaction. The primary endpoint is the change in the total MHQ score from baseline to Week 12.
Baseline, Week 4, Week 8, and Week 12 (Primary endpoint: change from baseline to Week 12)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Joint Position Sense (Proprioception)
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12
Wrist, metacarpophalangeal (MCP), and proximal interphalangeal (PIP) joint proprioception will be assessed using a joint position reproduction test with a goniometer. The mean absolute repositioning error from three trials will be recorded.
Baseline, Week 4, Week 8, and Week 12
Nine-Hole Peg Test
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12
Hand dexterity will be assessed using the Nine-Hole Peg Test. The average completion time of two trials for each hand will be recorded in seconds.
Baseline, Week 4, Week 8, and Week 12
Duruöz Hand Index
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12
Hand functional disability will be evaluated using the Duruöz Hand Index. Higher scores indicate greater disability.
Baseline, Week 4, Week 8, and Week 12
Pain Intensity
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12
Pain intensity during rest, activity, and night will be assessed using a 10-cm Visual Analog Scale (VAS). Higher scores indicate greater pain.
Baseline, Week 4, Week 8, and Week 12
Sensory Threshold
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12
Cutaneous sensory threshold will be evaluated using Semmes-Weinstein monofilaments. The thinnest monofilament perceived by the participant will be recorded.
Baseline, Week 4, Week 8, and Week 12
Grip Strength
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12
Maximum hand grip strength will be measured using a Jamar dynamometer. The average of three maximal contractions will be recorded in kilograms.
Baseline, Week 4, Week 8, and Week 12
Pinch Strength
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12
Lateral pinch and three-jaw chuck pinch strength will be measured using a Baseline pinch gauge. The average of three trials will be recorded in kilograms-force.
Baseline, Week 4, Week 8, and Week 12
Range of Motion
Ramy czasowe: Baseline, Week 4, Week 8, and Week 12
Active range of motion of the wrist and finger joints will be measured using standard goniometers and recorded in degrees.
Baseline, Week 4, Week 8, and Week 12

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Istanbul University - Cerrahpasa

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 października 2026

Zakończenie podstawowe (Szacowany)

28 grudnia 2027

Ukończenie studiów (Szacowany)

30 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

5 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

10 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

14 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IstanbulUC-FTR-BT-02

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data will not be made publicly available. Data will be retained by the investigators in accordance with institutional policies and ethical approval, and no current plan exists for external data sharing.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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